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Suppliers and packagers for LIPOFEN
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LIPOFEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612 | NDA | ANI Pharmaceuticals, Inc. | 62559-305-90 | 90 CAPSULE in 1 BOTTLE (62559-305-90) | 2021-09-24 |
| Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612 | NDA | ANI Pharmaceuticals, Inc. | 62559-306-90 | 90 CAPSULE in 1 BOTTLE (62559-306-90) | 2021-09-24 |
| Cipher Pharms Inc | LIPOFEN | fenofibrate | CAPSULE;ORAL | 021612 | NDA AUTHORIZED GENERIC | ANI Pharmaceuticals, Inc. | 62559-460-90 | 90 CAPSULE in 1 BOTTLE (62559-460-90) | 2016-04-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Lipofen
Introduction
Lipofen (fenofibrate) is a lipid-modifying agent primarily used to reduce elevated LDL cholesterol, triglycerides, and to increase HDL cholesterol. It is prescribed for managing hyperlipidemia and preventing cardiovascular disease. The global supply chain for Lipofen hinges on a network of reputable suppliers and manufacturers that ensure consistent quality, regulatory compliance, and timely delivery. This report analyzes key suppliers involved in the production, distribution, and supply of Lipofen, highlighting market dynamics, manufacturing capacities, regulatory considerations, and procurement strategies.
Manufacturers of Fenofibrate (Lipofen’s Active Pharmaceutical Ingredient)
Lipofen's formulation contains fenofibrate as the active pharmaceutical ingredient (API). The supply chain begins with manufacturers of fenofibrate, which are often integrated within larger pharmaceutical companies or contract manufacturing organizations (CMOs).
Major API Manufacturers
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AbbVie Inc.
- Overview: AbbVie is a leading global biopharmaceutical company with a significant footprint in cardiovascular drugs. It manufactures fenofibrate as part of its lipid management portfolio.
- Supply Role: Provides high-quality API for Lipofen production, leveraging extensive R&D and manufacturing facilities.
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Sandoz (Novartis Division)
- Overview: Sandoz is a pioneer in generic pharmaceuticals, offering fenofibrate API for generic and branded formulations.
- Supply Role: Supplies bulk fenofibrate to contract manufacturers and pharmaceutical companies worldwide.
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Mitsubishi Tanabe Pharma Corporation
- Overview: A Japanese pharmaceutical leader with a diversified portfolio, including fenofibrate. Their manufacturing sites in Japan and Asia serve global markets.
- Supply Role: Key API provider for Asian and international markets, including formulations like Lipofen.
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Zhejiang Medicine Co., Ltd.
- Overview: A prominent Chinese pharmaceutical firm with a robust API manufacturing platform, especially for cardiovascular agents.
- Supply Role: Supplies fenofibrate API to domestic and global formulators, often at competitive prices.
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SK Biotek
- Overview: A South Korean API manufacturer with capabilities in producing fenofibrate at high GMP standards.
- Supply Role: Supplies to both generic drug manufacturers and proprietary formulations.
Formulation and Final Product Suppliers of Lipofen
Lipofen is a branded formulation developed and marketed primarily by Daiichi Sankyo. The manufacturing partners for the finished drug involve contract manufacturing organizations and licensed pharmaceutical entities.
Key Formulation and Production Partners
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Daiichi Sankyo Company
- Overview: The original developer and marketer of Lipofen, leveraging its extensive manufacturing facilities in Japan.
- Supply Chain Role: Ensures consistent supply, quality control, and regulatory compliance in the production of Lipofen tablets.
-
Contract Manufacturing Organizations (CMOs)
Several CMOs globally produce Lipofen under licensing agreements with Daiichi Sankyo. These include facilities in India, China, and the Philippines, operating under Good Manufacturing Practice (GMP) standards.- Examples:
- Aurobindo Pharma (India)
- Zydus Cadila (India)
- Cipla (India)
- Examples:
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Generic Manufacturers
Following patent expiry or licensing provisions, generic manufacturers produce fenofibrate formulations similar to Lipofen. While these are not Lipofen-branded, they constitute a significant portion of available supply.
Supply Chain Dynamics and Market Considerations
Global Supply and Geographic Distribution
The global supply chain for Lipofen involves API manufacturing predominantly based in Asia (China, India, South Korea) and Japan. These regions benefit from lower production costs and high manufacturing standards. Finished formulations are distributed worldwide, with major markets in North America, Europe, and Asia.
Regulatory Environment
Manufacturers must navigate regulatory approvals from agencies like the FDA (U.S.), EMA (Europe), and PMDA (Japan). Ensuring compliance affects supply stability, especially amid evolving Good Manufacturing Practices (GMP) standards.
Market Trends and Impact on Suppliers
- Generic Drug Expansion: As fenofibrate patents expire, an increase in generic options poses competitive pressure on branded Lipofen supply.
- Supply Chain Disruptions: COVID-19 underscored vulnerabilities in global manufacturing, affecting API and finished product availability. With reliance on Asian manufacturing hubs, geopolitical and logistics factors influence supply security.
- Quality Assurance: Regulatory authorities increasingly emphasize quality standards, compelling suppliers to uphold rigorous testing and validation procedures.
Key Risks and Opportunities in Lipofen Supply
Risks:
- Dependence on Asian API manufacturers could lead to supply disruptions.
- Regulatory delays may hinder market access for new suppliers.
- Price fluctuations due to raw material costs and geopolitical tensions.
Opportunities:
- Diversification of API sourcing to mitigate risks.
- Advanced manufacturing technologies offering higher yields and cost efficiencies.
- Strategic partnerships and licensing agreements to expand supply capacity.
Conclusion
The supply of Lipofen hinges on a complex global network of API manufacturers, formulation partners, and regulatory pathways. Key API suppliers include AbbVie, Sandoz, Mitsubishi Tanabe Pharma, Zhejiang Medicine, and SK Biotek. The final formulation is produced by Daiichi Sankyo and its licensed CMOs, with a dynamic interplay between branded and generic markets. Ensuring resilient and compliant supply chains is critical for maintaining Lipofen’s market position amidst evolving global pharmaceutical landscapes.
Key Takeaways
- Leading fenofibrate API suppliers include AbbVie, Sandoz, Mitsubishi Tanabe, Zhejiang Medicine, and SK Biotek.
- Manufacturing is concentrated in Asia and Japan, with finished formulations produced via global CMOs.
- Regulatory compliance and supply chain resilience are crucial amid geopolitical and pandemic-related challenges.
- The expanding generic market increases competition but underscores the importance of high-quality manufacturing standards.
- Diversifying sourcing and leveraging technological advances can enhance supply stability for Lipofen.
FAQs
1. Who are the primary API suppliers of fenofibrate used in Lipofen?
Major API manufacturers include AbbVie, Sandoz (Novartis), Mitsubishi Tanabe Pharma, Zhejiang Medicine, and SK Biotek, primarily based in Asia and Japan.
2. Are there regional differences in Lipofen manufacturing?
Yes. The API is predominantly produced in Asia (China, India, South Korea), with finished formulations assembled in Japan and distributed globally.
3. How does patent expiration impact Lipofen’s supply chain?
Patent expiry facilitates generic competition, increasing supply options but also necessitating high-quality standards to ensure consistent efficacy and safety.
4. What regulatory challenges influence Lipofen’s supply stability?
Compliance with GMP standards, approval from agencies like the FDA and EMA, and adherence to evolving quality guidelines are critical to maintaining supply.
5. What are the prospects for suppliers amid current global trends?
Diversifying sourcing strategies, investing in advanced manufacturing, and forging strategic partnerships will be key to mitigating risks and ensuring consistent Lipofen supply.
Sources:
- U.S. Food & Drug Administration. Drug Approvals and Guidance.
- Pharmaceutical Technology. API Manufacturing and Supply Chain Insights.
- Daiichi Sankyo Company Reports.
- GlobalData Pharma Intelligence. Market Reports on Fenofibrate.
- Sandoz official product portfolio and API sourcing information.
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